ES2937435T3 - Surgical access device comprising an internal retractor - Google Patents

Abstract

Devices, Methods and Systems provide a surgical access device comprising an internal retractor device integrated into or attached to a body wall or wound retractor. The wound retractor retracts an opening in a body wall into a body cavity, while the internal retractor allows the user to control the positions of internal structures within the body cavity, thus allowing the user to define a surgical field. The internal retractor embodiments are adjustable. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Surgical access device comprising an internal retractor

BACKGROUND

technical field

The present invention relates to a surgical access device comprising a wound retractor and an internal retractor.

Description of Related Art

Abdominal surgical procedures often involve entry into a patient's abdominal cavity and subsequent manipulation of internal structures therein, such as the small intestine, colon, mesentery, and other fatty structures. For example, large portions of a patient's small intestine are often displaced to provide clear access to the patient's spleen in some surgical procedures thereon. Gauze and/or sponges are often used to contain displaced structures. However, gauze pads and/or sponges often slip and/or are difficult to place, especially through smaller incision sites. Gauze and/or sponges are usually also carefully considered during surgery, thus avoiding any remaining inside the patient.

Recent abdominal surgical procedures prefer smaller incisions, eg laparoscopic surgeries. Laparoscopic surgical procedures often involve multiple small incisions between about five millimeters and about twelve millimeters. Some more complex procedures include a single, larger incision. For example, a two-inch incision in the umbilicus that is circumferentially retracted by a circular wound retractor accommodates several laparoscopic instruments at the same time, or even a surgeon's hand reaching into the abdominal cavity. It is desirable to maintain a clear operative area within the abdominal cavity while limiting the access area.

Additionally, surgical procedures of the lower abdomen and pelvis are also performed using single-incision techniques, where an unobstructed and unrestricted working space is also desirable. Examples of wound retractors suitable for the above purposes are disclosed in US patent documents covering US Publications Nos. 2005/273132, 2006/074278, 6,033,426, 4,945,932, 2005/209510 and 2004/073090.

SUMMARY OF THE INVENTION

In accordance with the present invention, there is provided a surgical access device as set forth in claim 1. Preferred embodiments are set forth in the dependent claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGURE 1A is a front view of a patient for abdominal surgery.

FIGURE 1B is a partial frontal cross section illustrating abdominal contents. FIGURE 1C is a partial frontal cross section of a patient schematically illustrating the placement of a wound retractor in the abdomen. FIGURE ID is a partial lateral cross section of a patient illustrating the placement of a wound retractor in the abdomen.

FIGURE 2 is a perspective view of an access device comprising an internal retractor comprising a plurality of conformable members.

FIGURE 3 is a perspective view of another embodiment of an access device comprising an internal retractor comprising an inflatable member.

FIGURE 4 is a perspective view of an internal retractor of a surgical access device in accordance with the present invention, the internal retractor comprising a flat deformable frame.

FIGURE 5A is a partial lateral cross section of a patient prior to deploying an internal retractor in the abdomen. FIGURE 5B is a partial frontal cross section and FIGURE 5C is a partial lateral cross section of a patient in whom an internal retractor has been deployed in the abdomen. Similar reference characters refer to similar features throughout the document.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

FIGURE 1A is a front view of a patient 10 for surgery on the abdomen 20 with an incision site 22 at the navel. FIGURE 1B is a partial cross section illustrating abdominal contents 30 confined by a body wall 40, various attachments and connections. Content 30 is generally wet, slippery and difficult to handle, and is especially true for the small intestine 32. As shown schematically in FIGURE 1C and in partial lateral cross-section in FIGURE 1D, a circular retractor 50 is placed through an incision in the body wall 40 and into an abdominal cavity 42, thus providing the surgeon clear access. to abdominal content 30.

FIGURE 2 is a perspective view of a surgical access device 200 comprising a wound retractor 250 and an adjustable internal retractor 270 . Wound retractor 250 is disposed at a proximal end 202 of device 200, and internal retractor 270 is disposed at a distal end 204. A longitudinal axis 206 extends from the proximal end 202 to the distal end 204. An access channel 208 extends through the device 200.

In the illustrated embodiment, wound retractor 250 comprises a proximal or outer ring 252; a deformable inner or distal ring 254; and a flexible tubular sheath 256 disposed between the outer ring 252 and the inner ring 254.

The inner ring 254 is deformable or flexible, which allows the user to insert the inner ring 254 through an incision or opening in a body wall with a diameter less than a relaxed diameter of the inner ring 254, and into a body cavity. Inner ring 254 is also rigid enough to resist deformation when disposed against an interior surface of the body wall and under tension from tubular sheath 256 extending through the incision or opening.

Wound retractor 250 may be adjustable or non-adjustable, but in the illustrated arrangement, wound retractor 250 is an adjustable wound retractor. The outer ring 252 is rotatable about an annular axis thereof, which winds and/or unwinds the tubular sheath 256 around, thus setting an effective length of the tubular sheath 256 and a distance between the outer ring 252 and the inner ring 254. This adjustability allows a user to retract an opening or wound into a body cavity. The illustrated outer ring 252 comprises a first tube 252a and a second tube 252b. In other embodiments, the outer ring 252 has another shape, for example, comprising an oval, elliptical and/or elongated cross section, with a major or longer axis parallel or perpendicular to the longitudinal 206. The outer ring 252 further comprises one or more circumferential lumens and/or a wire or ring disposed in one or more of the lumens. Wires or rings may not meet the requirements and rings may be one ring or split rings.

Outer ring 252, inner ring 254, and tubular sheath 256 independently comprise any suitable biocompatible material, eg, one or more polymeric resins. Where outer ring 252 comprises a wire or ring, the wire or ring may comprise at least one of metal, stainless steel, spring steel, nitinol, polymer, ceramic, fibers, composites thereof, and the like.

Retractor 250 can be made in a plurality of sizes, for example, diameters of at least one of outer rings 252, inner ring 256, and sheath 256, and/or length of sheath 256. Some embodiments of access device 200 further comprise a stopper or lid (not illustrated) attachable to the outer ring 252, which closes and/or seals the access channel 208. The plug or lid may allow access of instruments and/or hands through the plug or lid and into the access channel 208. Suitable wound retractors, plugs or caps are also disclosed in US Pat. 7,727,146; 7,650,887; and 7,704,207, and publication no. 2010/0094227 A1. US patent application

Inner retractor 270 is attached to inner ring 254 of retractor 250 and extends distally from inner ring 254. The inner retractor 270 comprises a plurality of a plurality of elongated conformable members 272, each extending distally from the inner ring 254 of the wound retractor 250. In this arrangement each conformable member 272 recedes from the longitudinal axis 206, although in other arrangements, one or more of the conformable members 272 extends in a different direction, for example, substantially parallel to the longitudinal axis 206 and/or toward the longitudinal axis. 206 longitudinal.

Each formable member 272 comprises an elongated segment and/or a wing comprising any suitable material, for example at least one of polymeric resin or metal. Some embodiments of the formable members 272 comprise an elastically deformable material, eg, metal, stainless steel, spring steel, polymer, fibers, and combinations thereof. The conformable members 272 may comprise a malleable and/or plastically deformable material, eg, metal, stainless steel, a superelastic material, a shape memory material, clay, clay-like material, and combinations thereof. One or more of the conformable members 272 may be partially or completely encased and/or covered with at least one of fabric, gauze, and foam, thus improving traction and/or fluid absorption. One or more of the conformable members 272 may be partially or completely encased and/or covered with a fluid repellent and/or fluid impervious material. One or more of the conformable members 272 may comprise a textured and/or non-slip surface. The formable members 272 may comprise, for example, wire, strip, foil, and perforated foil.

One or more of the conformable members 272 may be curved along a transverse axis, thus stiffening the conformable members 272 using the principle that stiffens the slats of a Venetian blind. In the illustrated arrangement, at least one of an angle with the longitudinal axis 206, and one shape of each member 272 The individual conformable is adjustable, thereby retracting structures or organs and/or preventing structures or organs from entering a selected surgical area or field, thereby improving access to surgical targets therein. For example, at least a part of a conformable member 272 may be flexible transverse to a local longitudinal axis 274 thereof, at least a part of a conformable member 272 may be flexible or twist about the local longitudinal axis 274.

At least one of the formable members 272 can be integrated with the inner ring 254. At least one of the formable members 272 can be made separately and then attached to the inner ring 254. For example, inner ring 254 may comprise at least one connecting feature to which formable members 272 are attached. A proximal end of at least one conformable member 272 may comprise a connecting feature that secures the conformable member 272 to inner ring 254 at a desired angle with respect to longitudinal axis 206. Suitable connection features include, for example, mechanical fasteners, clips, clamps, friction fittings, Velcro fasteners, clips, zip ties, screws, latches, gaskets, hinges, ball joints, live hinges, and the like. The conformable members 272 can be attached to the inner ring 254 as a unit, eg, attached by a web and/or a ring at a proximal end of the inner retractor 270. In some arrangements, formable members 272 are individually attached to inner ring 254. One or more of the formable members 272 may be removable as desired, eg, by cutting, snapping, and the like. Internal retainer 270 may be removable, for example, after completing part of a surgical procedure. The internal 270 retractor, although they cannot be attached to a wound retractor and are used independently of the wound retractor.

In the illustrated embodiment, the local axis 274 of each formable member 272 is substantially normal to the inner ring 254, but the local axis 274 of at least one formable member 272 could subtend another angle with the inner ring 254 in a generally helical configuration. For example, all of the formable members 272 together could define a helical internal retractor 270 .

The internal retractor 270 could further comprise a dam or cover (not shown) that can be secured to one or more of the conformable members 272, thus defining an umbrella-like structure, which enhances retraction of internal organs. The cover is similar to the dock parts described and illustrated below, and like the dock parts, it comprises a single part or a plurality of parts and similar materials. The cover is permanently or temporarily secured, for example, using adhesive, pressure sensitive adhesive, mechanical fasteners, clips, clamps, friction fittings, Velcro fasteners, clips, zip ties, screws, latches, and the like. In some embodiments, the cover comprises one or more pockets sized to receive one or more of the members 272 formable therein. The user can remove one or more parts of the cover, for example by cutting or tearing it.

FIGURE 3 is a perspective view of a surgical access device 300 generally similar to that discussed above. The access device 300 comprises a proximal end 302, a distal end 304, a longitudinal shaft 306, an access channel 308, a wound retractor 350 disposed at the proximal end 302, and an adjustable internal retractor 370 disposed at the end 304 distal. Wound retractor 350 is generally similar to wound retractor 250 described above, and comprises an outer ring 352, an inner ring 354, and a flexible sheath 356. Internal retractor 370 is either integrated with wound retractor 350 or manufactured as a separate component, which is pre-attached to wound retractor 350 or attached to the user, or used without attachment to a wound retractor, as discussed above.

Inner retractor 370 comprises a plurality of longitudinally extending inflatable support members 372 and a plurality of dam portions 374 that extend between adjacent support members 372 . Alternatively, a single dam portion 374 could extend across a plurality of inflatable support members 372. The internal retractor also comprises a peripheral ring 376. Peripheral ring 376 could be in fluid connection with at least one support member 372, and is therefore inflatable with at least one support member 372. In other arrangements, peripheral ring 376 is non-inflatable. Peripheral ring 376 may comprise a plurality of attached members, eg, ball segments. In the illustrated arrangement, the inner retractor 370 is generally frustoconical in an inflated state, diverging distally from the longitudinal axis 304.

The illustrated internal retractor 370 comprises an open area, or window 378, which allows access to tissues and/or organs outside the perimeter of the internal retractor 370. The open area or window 378 allows a surgeon to place instruments and/or a hand in areas above, to the side, and/or below the internal retractor 370, which is useful, for example, when working on the lower abdomen or upper abdomen. pelvis. Some arrangements comprise a plurality of open areas or windows 378. Some internal retractor 370 arrangements do not comprise an open area or window. The internal retractor 370 can be provided without an open area or window 378, and the user can create one or more as desired, for example by removing selected dam portions 374 . The spacing of the support members 370 need not be uniform, allowing the user to select the desired size of the open area or window 378.

Inner retractor 370 may comprise at least one of rubber, polymeric resin, fabric, foam, and elastomer. The Support members 372, dam portions 374, and peripheral ring 376 may comprise different materials. The dam portions 374 may comprise at least one of polymer, membrane, film, rubber, tape, gauze, film, cloth, woven, nonwoven, and knitted cloth. The dam portions 374 may comprise an elastomeric or stretchable material, eg, Lycra. The inner retractor 370 may further comprise at least one flexible reinforcing member, for example, one or more ribs disposed on, through, or within at least one support member 372, dam portion 374, and/or peripheral ring 376. . At least one reinforcing support member 372 may be elastically deformable or plastically deformable. Suitable materials for the support member are described above. Suitable materials for reinforcing members 372 include at least one of metal, super elastic material, shape memory material, polymer, fibers, and composites thereof. The reinforcing members may comprise at least one of wires, strips, bands, and the like.

FIGURE 4 is a perspective view of an internal retractor 1270 of a surgical access device in accordance with the present invention, which is similar to the internal retractors described above. The internal retractor 1270 is integrated or coupled with a wound retractor, as discussed above. The illustrated embodiment of internal retractor 1270 comprises a longitudinal shaft 1206 extending between a proximal end 1202 and a distal end 1204, a deformable frame 1272, and a cover or dam portion 1274. The internal retractor 1270 comprises a connection feature 1280, which allows the internal retractor 1270 to be attached to a wound retractor, as discussed above. Frame 1272 defines a generally rectangular internal retractor 1270. In other embodiments, the frame 1272 defines a different shape, eg, trapezoidal or rhomboid. Frame 1272 is serpentine in the illustrated embodiment. In other embodiments, the frame 1272 has a different structure, for example, a lattice, a mesh, a solid sheet, a perforated sheet, or a combination of structures. The frame 1272 comprises a plastically deformable material, an elastically deformable material, or a combination of these. In embodiments comprising a plastically deformable material, the internal retractor 1270 is reshapeable or adjustable on deployment.

In the illustrated embodiment, the inner retractor 1270 further comprises a cover or dam portion 1274, as discussed above. Other embodiments do not comprise a deck or dock portion. Some embodiments can be reshaped, for example, by cutting out portions of frame 1272 and/or cover 1274, which allows for additional adjustability.

A method of using a surgical access device in abdominal surgery, not forming part of the invention, is schematically illustrated in FIGS. 5A-5C and described with reference to the embodiment of access device 300 illustrated in FIG. 3, although a skilled in the art will understand that the method is also applicable to all access devices described herein. FIGURE 5A is a partial lateral cross section of a patient in which a wound retractor 350 is placed through a body wall 40 and into a body cavity 42, which is an abdominal cavity in this case. Inner ring 354 and inner retractor 370 are first inserted through an incision in body wall 40 into body cavity 42. The outer ring 352 then inverts or rotates around itself, thus wrapping the tubular sheath 356 around the outer ring 352, thus retracting the incision. The outer ring 352 of the proximal part can, in some arrangements, be easily invertible in a snapping motion, providing a neutral position that resists rotation under the stress generated in the retraction process. The tension secures the retractor 350 to the body wall 40.

The abdominal cavity 42 is inflated with gas, which facilitates access to the internal structures 30. A plug or cover (not shown) may be secured to the proximal portion of the retractor 350, thus creating a substantially gas-tight seal for the body cavity 42, after which, the body cavity 42 is inflated or insufflated, for example, with CO2 gas.

Internal retractor 370 is then deployed as desired within body cavity 42, thereby retracting or retaining internal structures during the surgical procedure. FIGURE 5A illustrates the surgical site 70 prior to deployment of the internal retractor 370. For example, in the illustrated procedure, the position of the abdominal contents 30 is adjusted for an operation below the small intestine 32 . FIGURE 5B illustrates a partial frontal cross section and FIGURE 5C illustrates a partial lateral cross section of a retention pattern in which the internal retractor 370 holds the small intestine 32 away from the operative site 70 .

Deployment of the inner retractor 370 comprises positioning the peripheral ring 376 of the inner retractor 370, and inflating the inflatable support member 372 to a desired state of retention or retraction of the inner structures 30. The inflated internal retractor 370 retains or separates loose structures from the operative site 70 . When inserting the access device 300, as well as deploying the internal retractor 370, the internal retractor 370 is manipulated manually and/or with an instrument. For example, access device 300 may be sized and configured to access body cavity 22 with a surgeon's hand 100 through access channel 608 of port of access device 300. Other arrangements use a smaller access device 300 that is sized and configured to accept surgical instruments, such as laparoscopic tools, but not a hand. In some cases, using a single, smaller 300 device limits the number of incisions required in a laparoscopic procedure. Those skilled in the art will understand that the particular extensible member deployment procedure differs for each embodiment described above.

The invention has been described by way of example only and it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the scope of the invention as defined by the following claims.

Claims (15)

A surgical access device adapted to allow a user to control the position of internal structures within a body cavity, comprising a wound retractor (250) comprising a proximal or outer ring (252) adapted for disposition in the exterior of an opening in the body cavity, a distal or inner ring (254) adapted for disposition within the opening, and a flexible tubular sheath (256) extending between the proximal or outer ring (252) and the distal or inner ring, the surgical access device further comprising an inner retractor (1270) coupled to or integrated with the distal or inner ring (254) of the wound retractor (250) in an operative state of the surgical access device, the retractor internal (1270) comprising a flat deformable frame (1272), wherein, in the operative state, at least a portion of the internal retractor extends distally from the distal or internal ring (254) of the wound retractor (250) toward the body cavity and is configured to maintain a planar shape to retain structures away from an operative site within the body cavity. The surgical access device of claim 1, wherein the internal retractor (1270) and the wound retractor (250) are integrated. The surgical access device of claim 1, wherein the internal retractor (1270) is arranged to engage the wound retractor (250) in the operative state. The surgical access device of claim 1 or 3, wherein the internal retractor (1270) further comprises a connecting feature (1280), wherein the connecting feature (1280) engages the internal retractor (1270) to the retractor. (250) wounds. The surgical access device of claim 1, wherein the planar deformable frame (1272) defines a generally rectangular shape. The surgical access device of claim 1, wherein the planar deformable frame (1272) defines a generally non-rectangular shape. The surgical access device of claim 1, wherein the planar deformable frame (1272) defines a generally serpentine shape. The surgical access device of claim 1, wherein the deformable planar frame (1272) comprises at least one of a lattice, a mesh, a solid sheet, and a perforated sheet. The surgical access device of claim 1 or 9, further comprising a cover or dam (1274) disposed over the flat deformable frame (1272). The surgical access device of claim 9, wherein the cover or dam (1274) has a plurality of cutting portions, and wherein the internal retractor (1270) comprises at least one window through the cover or dam ( 1274) arranged on the frame (1272) deformable plane formed by cutting the cut parts associated with the deck or dock (1274). The surgical access device of claim 1, wherein the planar deformable frame (1272) comprises a plastically deformable material. The surgical access device of claim 1, wherein the frame comprises an elastically deformable material. The surgical access device of claim 9, wherein the flat deformable frame (1272) is configured to be further adjusted by cutting one or more portions of the cover or dam (1274). The surgical access device of claim 1 or 13, wherein the flat deformable frame (1272) is configured to be further adjusted by cutting one or more portions of the flat deformable frame (1272). The surgical access device of claim 6, wherein the planar deformable frame (1272) defines a trapezoidal or rhomboid shape.